PKG00288120.pdf

FY23 – FY27 DOD USAMRDC Broad Agency Announcement for Extramural Medical Research – 1 General Submission Instructions

General Submission Instructions

Broad Agency Announcement for Medical Research

Fiscal Year 2023 – Fiscal Year 2027

Department of Defense

U.S. Army Medical Research and Development Command

Table of Contents

I. HELPFUL INFORMATION

A. Tips for Success B. Current Funding Opportunity Announcement C. Receiving Emails from eBRAP and Grants.gov D. Agency Contacts

II. REGISTRATION AND SUBMISSION INFORMATION

A. eBRAP Registration B. Content and Form of Pre-Proposal/Pre-Application Submission

III. CONTENT AND FORM OF PROPOSAL/APPLICATION SUBMISSION FOR

RESEARCH PROPOSALS/APPLICATIONS

A. Grants.gov Submission Package Components B. Submission to Grants.gov C. Applicant Verification of Grants.gov Submission in eBRAP D. Proposal/Application Tracking

APPENDIX 1 REGULATORY REQUIREMENTS

A. Safety and Environmental Requirements B. Research Protections Review Requirements C. Human Subjects Research D. Research Involving the Secondary Use of Human Data and/or Human Anatomical

Substances E. Use of Unique or Regulated Sample Types F. Use of Human Cadavers or Human Anatomical Substances Obtained from Human

Cadavers G. Large-Scale Genomic Data (LSGD) Collected from DOD-Affiliated Personnel H. Additional Information/Requirements I. DoD Instruction Use of DOD or Department of Veterans Affairs (VA) Resources

APPENDIX 2 REPORTING REQUIREMENTS AND ADMINISTRATIVE

INFORMATION

A. Reporting Requirements for Awards B. Post-Award Organization and Principal Investigator Changes

FY23 – FY27 DOD USAMRDC Broad Agency Announcement for Extramural Medical Research – 2

C. Disclosure of Proprietary or Confidential Information D. Marking of Proprietary or Confidential Information E. Award Notices F. Inquiry Review Process (IRP) G. Information Service H. Freedom of Information Act Requests I. Information Release J. Contracted Fundamental Research K. Sharing of Proposal/Application Information L. Sharing of Data and Research Resources M. Property/Equipment N. Title to Inventions and Patents

APPENDIX 3 QUALIFICATION AND RESTRICTIONS INFORMATION

A. Contractor/Recipient Qualification B. Eligibility Information C. J-1 Visa Waiver D. Conflict of Interest

APPENDIX 4 FORMATTING GUIDELINES

APPENDIX 5 NATIONAL POLICY REQUIREMENTS

A. Certification B. Representations

APPENDIX 6 ACRONYM LIST

This General Submission Instructions document must be read in conjunction with the broad agency announcement, available for downloading from Grants.gov.

FY23 – FY27 DOD USAMRDC Broad Agency Announcement for Extramural Medical Research – 3

I. HELPFUL INFORMATION

A. Tips for Success

This symbol marks helpful hints throughout this document.

This symbol refers to the funding opportunity announcement/broad agency announcement

(BAA) for specific instructions.

B. Current Funding Opportunity Announcement

The Fiscal Year 2023 – Fiscal Year 2027 (FY23 – FY27) U.S. Army Medical Research and

Development Command’s (USAMRDC) BAA can be found by searching Grants.gov

(https://www.grants.gov/) using the Funding Opportunity Number HT942523SBAA1 or the

Assistance Listing Number 12.420 Military Medical Research and Development.

The execution management agent for this BAA will be the Congressionally Directed Medical

Research Programs (CDMRP). Additional information may be found on the CDMRP’s electronic Biomedical Research Application Portal (eBRAP) website at https://ebrap.org/eBRAP/public/index.htm.

The awarding agency will be the U.S. Army Medical Research Acquisition Activity

(USAMRAA). The USAMRAA Contracting/Grants/Agreements Officers are the only individuals authorized to obligate funds and bind the federal government for awards under this

BAA.

C. Receiving Emails from eBRAP and Grants.gov

To help ensure that all email correspondence is delivered correctly and is not treated as spam, keep your email address up to date in eBRAP and Grants.gov and place the following domains into your safelist: army.mil, us.army.mil, health.mil, *.mail.mil, eBRAP.org, and Grants.gov.

Also use the same email address when submitting both the pre-proposal/pre-application to eBRAP and the full proposal/application to Grants.gov.

The applicant is responsible for using the latest version of the full proposal/application package

(hereinafter, submission package). It is incumbent upon the applicant to check for published updates to the funding opportunity and the submission package prior to submission.

Proposals/applications submitted without the required components of the full submission package may be rejected. Applicants are encouraged to sign up to receive notifications of any changes to the funding opportunity (https://www.grants.gov/) through either (1) the “Send me change notification emails” link on the Synopsis page for the BAA or (2) by responding to the

Grants.gov prompt when first downloading the Grants.gov submission package.

D. Agency Contacts

1. eBRAP Help Desk: Questions related to BAA content or submission requirements, as well as questions related to submission of pre-proposals/pre-applications through eBRAP, should https://www.grants.gov/ https://ebrap.org/eBRAP/public/index.htm http://www.grants.gov/

FY23 – FY27 DOD USAMRDC Broad Agency Announcement for Extramural Medical Research – 4 be directed to the Help Desk, which is available Monday through Friday from 8:00 a.m. to

5:00 p.m. Eastern time. Response times may vary depending upon the volume of inquiries.

The eBRAP Help Desk will not provide Grants.gov submission assistance.

Phone: 301-682-5507 (Monday through Friday, 8:00 a.m. to 5:00 p.m.)

Email: help@ebrap.org

2. Grants.gov Contact Center: Questions related to proposal/application submission through the Grants.gov portal should be directed to the Grants.gov Contact Center, which is available

24 hours a day, 7 days a week (closed on U.S. federal holidays).

Phone: 1-800-518-4726; International: 1-606-545-5035

Email: support@grants.gov

II. REGISTRATION AND SUBMISSION INFORMATION

Submission is a two-step process requiring both (1) pre-proposal/pre-application submission through eBRAP (https://eBRAP.org/) and (2) full proposal/application submission through a

Grants.gov Workspace. General registration information is provided below. For detailed instructions, refer to the eBRAP User Guide (https://ebrap.org/eBRAP/public/UserGuide.pdf) for eBRAP registration, and https://www.grants.gov for Grants.gov registration.

Submission of proposals/applications from U.S. federal agencies and those proposing collaborations with military facilities have unique requirements. Budget requirements and restrictions apply. See Section III.A.5, Research & Related Budget and Section

III.A.8, Suggested DOD Collaborating Military Facility Budget Format.

For specific guidance regarding changes to the Principal Investigator (PI) or organization, refer to the BAA.

A. eBRAP Registration eBRAP (https://ebrap.org) is a secure web-based system that allows PIs to submit their pre-proposals/pre-applications, view and verify extramural full proposals/applications submitted to

Grants.gov, receive communications from the CDMRP, and submit documentation during award negotiations and throughout the period of performance.

All PIs must register in eBRAP to submit a pre-proposal/pre-application.

During eBRAP registration, the PI must request to be affiliated with their organization from the list of organizations already registered with eBRAP. If the PI’s organization is not already registered with eBRAP, the PI must invite an Authorized Organizational Representative (AOR) to register the organization. The AOR does not need to complete the organization registration in

PIs are encouraged to start the registration process for eBRAP early to ensure sufficient time for completion prior to the submission deadline. There is no grace period.

mailto:help@ebrap.org mailto:support@grants.gov https://ebrap.org/ https://ebrap.org/eBRAP/public/UserGuide.pdf https://www.grants.gov/web/grants/applicants/adobe-software-compatibility.html https://ebrap.org/

FY23 – FY27 DOD USAMRDC Broad Agency Announcement for Extramural Medical Research – 5 eBRAP prior to the pre-proposal/pre-application submission deadline in order for the pre-proposal/pre-application to be submitted. However, the organization’s eBRAP registration must be completed before the full proposal/application submission deadline to allow for processing, viewing, and modifying select components of the full proposal/application package.

Specific information must be identical between the pre-proposal/pre-application and the full proposal/application for eBRAP to process a proposal/application. The proposal/application title, eBRAP log number, and all information for the PI, Business Official(s), performing organization, and contracting organization must be consistent for the entire pre-proposal/pre-application and proposal/application submission process. Inconsistencies may delay proposal/application processing and limit or negate the ability to view, modify, and verify the proposal/application in eBRAP.

Applicants should ensure that their name and email address are the same as the name and email address on the Standard Form 424 Research and Related (SF424 Research & Related) Form of the

Grants.gov application package submitted through Grants.gov Workspace.

PIs are encouraged to utilize an Open Researcher and Contributor ID (ORCID) identifier and enter that information in the appropriate field in the “My Profile” tab in the “Account

Information” section of eBRAP. An ORCID will be required if an application is subsequently recommended for funding.

B. Content and Form of Pre-Proposal/Pre-Application Submission

For specific instructions regarding content of the pre-proposal/pre-application submission components, refer to the BAA.

All pre-proposal/pre-application components must be submitted through eBRAP

(https://eBRAP.org/) by the deadline specified in the BAA. Click on “Submit” and

“Confirm Submission” to complete the pre-proposal/pre-application submission.

During pre-proposal/pre-application submission, the PI must identify a Business Official from the list of Business Officials registered with eBRAP. If the PI’s Business Official is not already registered with eBRAP, the PI must invite the Business Official to register. This invitation to register must be sent prior to the pre-proposal/pre-application deadline. The Business

Official’s registration must be completed prior to the full proposal/application deadline to allow the Business Official to view, modify, and verify the full proposal/application in eBRAP after submission.

During pre-proposal/pre-application submission, the PI must select the performing organization

(site at which the PI will perform the proposed work) and contracting organization (organization submitting on behalf of the PI) and click on “Add Organizations to this Pre-application.” The organization(s) must be either selected from the eBRAP drop-down list or invited to allow submission of the pre-proposal/pre-application.

FY23 – FY27 DOD USAMRDC Broad Agency Announcement for Extramural Medical Research – 6

The pre-proposal/pre-application consists of the following components, which are organized in eBRAP by separate tabs:

Tab 1 – Proposal/Application Information: Enter the proposal/application information as described in eBRAP before continuing the pre-proposal/pre-application. Submission of proposal/application information includes assignment of primary and secondary research classification codes, which can be found at https://ebrap.org/eBRAP/public/Program.htm.

Applicants are strongly encouraged to review and confirm the codes prior to making their selection. Click on “Save.”

Tab 2 – Proposal/Application Contacts: Enter contact information for the PI. Enter the name of the organization’s Business Official responsible for sponsored program administration (the “person to be contacted on matters involving this application” in Block

5 of SF424 in the Grants.gov package). Depending on screen resolution, scrolling horizontally may be necessary to locate the box to “Invite an AOR” to register the performing and/or contracting organizations. Click on “Add Organizations to this Pre-application.” The Business Official must be either selected from the eBRAP list or invited to allow the pre-proposal/pre-application to be submitted. The Business Official must be either selected from the eBRAP list or invited in order for the pre-proposal/pre- application to be submitted.

If the organization’s Business Official is not in eBRAP, an invitation to the Business

Official to register in eBRAP must be sent.

Tab 3 – Collaborators and Key Personnel: Enter the name, organization, and role of all collaborators and key personnel associated with the proposal/application. Click on “Save.”

Note: The USAMRDC does not follow National Institutes of Health (NIH) guidelines for role designation of project participants. Unless otherwise noted in the BAA, applicants should assign the role of each participant in accordance with the participant’s respective involvement in the project.

Federal agency personnel involved in the review process and/or with making funding recommendations are prohibited from being involved in any pre-proposal/pre-application and full proposal/application, including, but not limited to, concept design, proposal/application development, budget preparation, and the development of any supporting documentation.

If formal collaboration with military facility personnel is planned (i.e., included in the proposal/application in performance of the research) those military facility personnel are prohibited from being involved in the review process and/or with making funding recommendations.

Tab 4 – Conflict of Interest (COI): To avoid COIs during the screening and review processes, list all individuals other than collaborators and key personnel who may have a

COI in the review of the proposal/application (including those with whom the PI has a personal or professional relationship). Click on “Save.”

https://ebrap.org/eBRAP/public/Program.htm

FY23 – FY27 DOD USAMRDC Broad Agency Announcement for Extramural Medical Research – 7

Tab 5 – Pre-Proposal/Pre-Application Files: Upload all documents as PDF as specified in the BAA. Documents should conform to the formatting guidelines outlined in Appendix

4. Click on “Upload.”

• eBRAP will truncate characters exceeding the limit specified for each data field as specified in the BAA, if applicable.

• eBRAP will not allow a document to be uploaded in the Required Files tab if the number of pages exceeds the limits specified in the BAA.

Tab 6 – Submit Pre-Proposal/Pre-Application: Enter eBRAP password and click the

“Submit” button. Click the “Confirm Submission” button to complete the pre-proposal/pre-application submission. This finalizes the pre-proposal/pre-application process.

The pre-proposal/pre-application is not submitted until Tab 6 is complete. Pre-proposals/pre-applications not completed remain in DRAFT status.

Following completion of pre-proposal/pre-application submission, the status of the pre-proposal/pre-application in eBRAP will change from “DRAFT” to “SUBMITTED,” and a confirmation email will be sent to the PI and named Business Official. A pre-proposal/ pre-application in DRAFT status will not be forwarded for review.

III. CONTENT AND FORM OF PROPOSAL/APPLICATION SUBMISSION FOR

RESEARCH PROPOSALS/APPLICATIONS

Grants.gov (https://grants.gov) is a federal system required to be utilized by agencies to receive and process extramural grant applications. Each proposal/application submission must include the completed full proposal/application package for the BAA. The full proposal/application package is submitted by the AOR through Grants.gov (https://www.grants.gov/) for extramural organizations.

Grants.gov applicants must apply online using Workspace, a shared, online environment where members of a grant team (investigators and Business Officials) may simultaneously access and edit different webforms within a proposal/application. Applicants must create a Workspace, invite grant team members to join the Workspace, complete the required forms, and submit their proposal/application Workspace package.

To apply through Grants.gov, an organization must first complete the Grants.gov registration process. Allow up to 8 weeks for the completion of the Grants.gov registration process.

Registering early is advised.

Foreign organizations doing business outside of the United States are also required to complete the Grants.gov registration process, in addition to fulfilling supplementary requirements for doing business with the U.S. federal government.

If business is conducted with the federal government on a continuing basis, it is likely that some of the actions have already been completed.

https://grants.gov/ https://www.grants.gov/

FY23 – FY27 DOD USAMRDC Broad Agency Announcement for Extramural Medical Research – 8

Detailed information, automated tools, and checklists are available at https://grants.gov/applicants/applicant-registration/.

The following steps are required as part of the Grants.gov registration process:

1. Unique Entity Identifier (UEI) and System for Award Management (SAM)

The applicant organization must be registered as an Entity in SAM (https://www.sam.gov/SAM/) and receive confirmation of an “Active” status before submitting a proposal/application through

Grants.gov.

AORs with existing eBRAP accounts should update their organizational profile to include the

UEI prior to submission of the full application to Grant.gov (see below).

SAM validates organization information and electronically shares the secure and encrypted data with federal agencies’ finance offices to facilitate paperless payments through electronic funds transfer. An organization must identify an accounts receivable point of contact (POC), an electronic business (E-Biz) POC, and a government business POC during the SAM registration process. Entity registrations in SAM have an annual expiration. Verify the status of your organization’s Entity registration in SAM well in advance of the proposal/ application submission deadline. An organization can register in SAM online at https://www.sam.gov/SAM/. If your organization does not have either an Employer

Identification Number (EIN) or Tax Identification Number (TIN), allow at least 2 weeks to receive this information from the U.S. Internal Revenue Service. Allow several weeks to complete the entire SAM registration process. If an applicant has not fully complied with the requirements by the time the federal awarding agency is ready to make a federal award, the federal awarding agency may determine that the applicant is not qualified to receive a federal award and use that determination to direct the federal award to a qualified applicant.

Additional information and step-by-step registration directions are detailed in the SAM User

Guide and other GSA training materials in the Help area at https://www.sam.gov/SAM.

Proposals/applications will be rejected by Grants.gov if (1) the organization’s Entity registration in SAM is not active or (2) during the SAM registration process, the organization did not answer “Yes” when asked, “Do you want to be eligible for grants and other federal assistance?”

2. Commercial and Government Entity (CAGE) Code

The applicant organization must have a CAGE code. The Defense Logistics Information Service in Battle Creek, Michigan, is the only authorized source of CAGE codes. CAGE codes will be assigned to registrants as their SAM registration advances through the validation process.

Foreign registrants in SAM must be assigned a North Atlantic Treaty Organization (NATO)

CAGE code (NCAGE). An NCAGE code can be obtained by contacting the National

Codification Bureau of the country where the organization is located or by visiting the website

(https://cage.dla.mil/Home/UsageAgree). On average, CAGE code or NCAGE code validation in

SAM occurs within 3 business days after the TIN is validated.

https://www.sam.gov/SAM/ https://www.sam.gov/SAM/ https://www.sam.gov/SAM https://cage.dla.mil/Home/UsageAgree

FY23 – FY27 DOD USAMRDC Broad Agency Announcement for Extramural Medical Research – 9

3. Authorized Organizational Representative

Each organization must have an AOR who is registered with Grants.gov (individual PIs do not register with Grants.gov). An AOR must be a member of the Grants.gov Workspace grant team as the Business Official authorized to submit the completed Workspace proposal/application package. An organization’s E-Biz POC in Grants.gov must authorize an AOR. An individual may serve as both the E-Biz POC and the AOR. Before proposal/application submission, the

AOR must be registered to submit on behalf of the organization at Grants.gov

(https://apply07.grants.gov/apply/register.faces).

An AOR must first register with the Grants.gov credential provider at https://apply07.grants.gov/apply/register.faces to obtain a username and password. Once an

AOR has completed the Grants.gov registration process, Grants.gov will notify the E-Biz POC of the registration. The E-Biz POC will then log in to Grants.gov and assign and authorize the appropriate roles, which may include the AOR role, thereby giving the AOR permission to complete and submit proposals/applications on behalf of the organization. When an E-Biz POC approves an AOR, Grants.gov will send the AOR a confirmation email.

At the time of proposal/application submission to Grants.gov, the AOR is certifying to the best of their knowledge that all information provided in the proposal/application is current, accurate, and complete.

For proposals/applications submitted through Grants.gov, the name of the AOR submitting the proposal/application is inserted into the application’s signature line, serving as the electronic signature.

Individuals who make legally binding commitments on behalf of an organization must be authorized as AORs by the E-Biz POC. This step, often overlooked by applicants, is crucial for valid and timely submissions.

4. Grants.gov Workspace

Applicants must create a Grants.gov Workspace, which allows the proposal/application components to be completed online and routed through the applicant organization for review prior to submission. Once the Workspace has been created, participants (grant team members) can be added, and the required forms can be completed and reviewed before submitting.

Each proposal/application submission must include the completed Grants.gov submission package of forms associated with the BAA in Grants.gov (https://www.grants.gov/).

Applicants who prepare the proposal/application outside Workspace must download the individual PDF forms from Grants.gov, complete and save the forms, and upload them to the

Workspace. A compatible and identical version of Adobe Reader must be used to view, complete, and submit a proposal/application package consisting of PDF forms if more than one person accesses the proposal/application package. Using different versions of Adobe Reader may cause submission and/or save errors – even if each version is individually compatible with

Grants.gov. Grants.gov will reject a submission package that is opened at any time by an individual with an incompatible version of Adobe Reader. Rejected proposals/applications https://apply07.grants.gov/apply/register.faces https://apply07.grants.gov/apply/register.faces http://www.grants.gov/

FY23 – FY27 DOD USAMRDC Broad Agency Announcement for Extramural Medical Research – 10 must be resubmitted using a new Grants.gov submission package and a supported version of

Adobe Reader prior to the proposal/application submission deadline. It is the applicant’s responsibility to verify their Adobe Reader’s compatibility with Grants.gov:

https://grants.gov/applicants/adobe-software-compatibility. A no-cost compatible version of

Adobe Reader can be downloaded at https://get.adobe.com/reader/otherversions/. All contributors to the proposal/application must use matching compatible versions of Adobe software when editing and preparing proposal/ application components outside the Workspace.

The use of different software versions will result in corruption of the submitted file.

The CDMRP cannot make allowances/exceptions to its policies for submission problems encountered by the applicant organization using system-to-system interfaces with Grants.gov.

Any modifications to the Project Narrative or Budget Form require submission of a changed/ corrected Grants.gov submission package to Grants.gov prior to the proposal/application submission deadline. The Project Narrative and Research & Related Budget Form cannot be modified during the proposal/application verification period.

The proposal/application submission deadline and the end of the proposal/application verification period in eBRAP are stated on the first page of the BAA. See Section III.C, Applicant Verification of Grants.gov Submission in eBRAP, for additional details.

A. Grants.gov Submission Package Components

1. SF424 (Research & Related), Application for Federal Assistance Form

All appropriate information must be entered into this form to allow for auto-population of subsequent forms in this Grants.gov submission package.

• Block 1 – Type of Submission. For original submissions, select the “Application” box.

For changes that must be made after the original submission, the complete Grants.gov submission package must be resubmitted with the “Changed/Corrected Application” box selected.

• Block 2 – Date Submitted. Enter the date the proposal/application is submitted.

• Applicant Identifier. Enter the submitting organization’s Control Number, if applicable.

If there is no Organization Control Number, leave this field blank.

• Block 3 – Date Received by State and State Application Identifier. Not applicable.

• Block 4a – Federal Identifier Box. Enter the eBRAP log number assigned during pre-proposal/pre-application submission.

Figure 1. Enter your eBRAP log number in Block 4a.

https://grants.gov/applicants/adobe-software-compatibility https://get.adobe.com/reader/otherversions/

FY23 – FY27 DOD USAMRDC Broad Agency Announcement for Extramural Medical Research – 11

• Block 4b – Agency Routing Identifier. Not applicable.

• Block 4c – Previous Grants.gov Tracking ID. For changed/corrected proposals/ applications, enter the Grants.gov tracking number for the original proposal/application.

• Block 5 – Applicant Information. Enter the information for the applicant organization.

“Person to be contacted on matters involving this application” is the Business Official.

• Block 6 – Employer Identification. Enter the EIN or TIN as assigned by the Internal

Revenue Service. If applying from an organization outside the United States, enter 44-

4444444.

• Block 7 – Type of Applicant. Enter the information for the applicant organization.

• Block 8 – Type of Application. Select “New” for all submissions.

• Block 9 – Name of Federal Agency. Populated by Grants.gov.

• Block 10 – Catalog of Federal Domestic Assistance Number. Populated by Grants.gov.

• Block 11 – Descriptive Title of Applicant’s Project. Enter the same project title as used for the pre-proposal/pre-application.

• Block 12 – Proposed Project. Enter the estimated start and end dates for the project.

Actual start and end dates will be determined during negotiations if the proposal/ application is recommended for funding.

• Block 13 – Congressional District of Applicant. If the applicant organization is outside the United States, enter 00-000.

• Block 14 – Project Director/Principal Investigator Contact Information. Enter information for the individual PI responsible for the overall scientific and technical direction of the proposal/application. If outside the United States, select the appropriate country from the drop-down menu.

• Block 15 – Estimated Project Funding. Enter the total funds (direct + indirect costs) requested for the entire performance period of the project. These figures should match those provided in the Research & Related Budget.

FY23 – FY27 DOD USAMRDC Broad Agency Announcement for Extramural Medical Research – 12

• Block 16 – Is Application Subject to Review by State Executive Order 12372

Process? Select option b., “NO, program is not covered by E.O. 12372.”

• Block 17 – Complete Certification. Select the “I agree” box to provide the required certifications and assurances. By checking “I Agree” on block 17 of the SF424 (R&R) the applicant agrees to abide by the following statement: “By signing this proposal/application, I certify the proposing entity is in compliance with Section 223(a) of the William M. (Mac) Thornberry National Defense Authorization Act for Fiscal

Year 2021 which requires that: (a) the PI and other key personnel certify that the current and pending support provided on the proposal/application is current, accurate and complete; (b) agree to update such disclosure at the request of the agency prior to the award of support and at any subsequent time the agency determines appropriate during the term of the award; and (c) the PI and other key personnel have been made aware of the requirements under Section 223(a)(1) of this Act. I am aware that any false, fictitious, or fraudulent statements or claims may subject me to criminal, civil, or administrative penalties.” (U.S. Code, Title 18, Section 1001 [18 USC 1001]). Checking

“I agree” confirms compliance with the National Policy Requirements, Appendix 5.

• Block 18 – SFLLL (Disclosure of Lobbying Activities) or Other Explanatory

Documentation. If applicable, complete and attach Standard Form LLL (SFLLL) to disclose lobbying activities pursuant to 31 USC 1352.

• Block 19 – Authorized Representative. Enter the contact information for the applicant organization’s authorized representative. The “Signature of Authorized Representative” is automatically completed upon submission of the Grants.gov submission package.

• Block 20 – Pre-Proposal/Pre-Application. Not applicable.

• Block 21 – Cover Letter Attachment. Not applicable.

2. Attachments Form

Grants.gov does not validate for the presence of attachments on the Attachments Form.

Following retrieval and processing of the Grants.gov proposal/application, eBRAP will notify the organizational representatives and PI by email to log into the eBRAP to view, modify, and verify the Grants.gov proposal/application submission. eBRAP will validate retrieved files against the specific BAA requirements, and discrepancies will be noted in both the email and in the Full

Application Files tab. eBRAP does not confirm the accuracy of file content. It is the applicant’s responsibility to review all proposal/application components and ensure proper ordering as specified in the BAA. See Section III.C, Applicant Verification of Grants.gov Submission in eBRAP, for additional details.

If a revised Project Narrative or Research & Related Budget Form document is needed, an updated Grants.gov submission package must be submitted via Grants.gov as a

“Changed/Corrected Application” with the previous Grants.gov Tracking ID found in

Block 4.c. of the SF424 Research & Related Form prior to the full proposal/application submission deadline.

FY23 – FY27 DOD USAMRDC Broad Agency Announcement for Extramural Medical Research – 13

Each attachment in the Attachment Form must be uploaded as an individual PDF file in accordance with the formatting guidelines listed in Appendix 4. For all attachments, ensure that the file names are consistent with the guidance listed in the BAA and below. Grants.gov will reject attachments with file names longer than 50 characters or incompatible file names that contain characters other than the following: A-Z, a-z, 0-9, underscore, hyphen, space, and period.

In addition, Grants.gov has file size limits that may apply in some circumstances. Individual attachments may not exceed 20 megabytes (MB), and the file size for the entire submission package may not exceed 200 MB. Applicants must contact the Grants.gov Contact Center

(support@grants.gov) for written confirmation that a file exceeding the maximum size will be accepted.

For specific instructions regarding content and page limits of the Project Narrative, Supporting Documentation, and all other attachments to this Grants.gov form, refer to the BAA.

All documents that require signatures must be signed. Both electronic and hand signatures will be accepted. Any document that is signed by hand should be scanned at a low resolution such as 100-150 dots per inch.

The following must be included as attachments to this form:

Attachment 1: Project Narrative: Attach as a PDF named “ProjectNarrative.pdf”.

The Project Narrative is the main body of the proposal/application. The page limit of the

Project Narrative applies to text and non-text elements (e.g., figures, tables, graphs, photographs, diagrams, chemical structures, drawings) used to describe the project.

Inclusion of URLs (uniform resource locators; web addresses) that provide additional information to expand on the Project Narrative and could confer an unfair competitive advantage is prohibited and may result in administrative withdrawal of the proposal/application.

Submission of a Project Narrative that exceeds the page limit specified in the BAA will result in administrative rejection of the proposal/application.

Attachment 2: Supporting Documentation: Combine and attach as a single PDF file named “Support.pdf”. Include only supporting documentation as indicated in the BAA.

Submitting material that is not requested may be viewed as an attempt to gain an unfair competitive advantage; such material will be removed, or the proposal/application may be administratively withdrawn. The Supporting Documentation attachment should not include additional information such as figures, tables, graphs, photographs, diagrams, chemical structures, or drawings. These items should be included in the Project

Narrative. Any additional material viewed as an extension of the Project Narrative will be removed or may result in administrative withdrawal of the proposal/application.

All proposals/applications are provided fair and thorough reviews. Letters of support not requested in the BAA, such as those from members of Congress, will be removed from the proposal/application package.

For a list and descriptions of required supporting documents, refer to the BAA.

mailto:support@grants.gov

FY23 – FY27 DOD USAMRDC Broad Agency Announcement for Extramural Medical Research – 14

The data management plan should include but is not limited to:

(1) The types of data, software, and other materials to be produced.

(2) How the data will be acquired.

(3) Time and location of data acquisition, if scientifically pertinent.

(4) How the data will be processed.

(5) The file formats and the naming conventions that will be used.

(6) A description of the quality assurance and quality control measures during collection, analysis, and processing.

(7) A description of dataset origin when existing data resources are used.

(8) A description of the standards to be used for data and metadata format and content.

(9) Appropriate timeframe for preservation.

(10) The plan may consider the balance between the relative value of data preservation and other factors such as the associated cost and administrative burden. The plan will provide a justification for such decisions.

(11) Include a statement that the data cannot be made available to the public when there are national security or controlled unclassified information concerns (e.g., “This data cannot be cleared for public release in accordance with the requirements in

DoD Directive 5230.09.”).

Submitting material that is not requested may be viewed as an attempt to gain an unfair competitive advantage; such material will be removed, or the application may be administratively withdrawn.

Attachment 3: Technical Abstract: Attach as a PDF file named “TechAbs.pdf”.

Abstracts of all funded research projects will be posted on the CDMRP website at https://cdmrp.health.mil. Do not include proprietary or confidential information. Use only characters available on a standard QWERTY keyboard. Spell out all Greek letters, other non-English letters, and symbols. Graphics are not allowed.

The technical abstract will be posted publicly and will be included in the award agreement. Do not include proprietary or confidential information.

Attachment 4: Lay Abstract: Attach as a PDF file named “LayAbs.pdf”. Abstracts of all funded research projects will be posted on the CDMRP website at https://cdmrp.health.mil. Do not include proprietary or confidential information. Do not duplicate the technical abstract. Use only characters available on a standard QWERTY https://cdmrp.health.mil/ https://cdmrp.health.mil/

FY23 – FY27 DOD USAMRDC Broad Agency Announcement for Extramural Medical Research – 15 keyboard. Spell out all Greek letters, other non-English letters, and symbols. Graphics are not allowed.

The lay abstract will be posted publicly. Do not include proprietary or confidential information.

Attachment 5: Statement of Work (SOW): Attach as a PDF file named “SOW.pdf”.

The SOW outlines and establishes the performance expectations and milestones for which

USAMRDC may provide funding. The SOW for all award types will be incorporated into the award document and, as such, is subject to release under Freedom of Information Act

(FOIA).

SOW Format: PIs are strongly encouraged to use the suggested SOW format stated in the

BAA. Templates for SOW formats are available on the eBRAP “Funding Opportunities &

Forms” page (https://ebrap.org/eBRAP/public/Program.htm). The SOW must be in PDF format prior to attaching.

There is no limit to the number of specific aims, tasks, or subtasks that are described within the SOW page limit. The suggested SOW format and examples specific to different types of research projects are available on the eBRAP “Funding Opportunities and Forms” web page (https://ebrap.org/eBRAP/public/Program.htm). The SOW must be in PDF format prior to attaching. The government reserves the right to request a revised SOW format and/or additional information.

The SOW should include a list of major tasks that support the proposed specific aims, followed by a series of subtasks outlined step-by-step as they relate to the major tasks and milestones within the period of performance. The SOW should describe only the work for which funding is being requested by the proposal/application and, as applicable, should also:

• Include the following information for each study site/subaward site: Organization;

organization address; investigator(s), collaborator(s), consultant(s); description of research with animals, human anatomical substances, human data and/or human subjects or cadavers to be conducted at the site; and key personnel responsible for each major task and each subtask to be performed at the site.

• Indicate the number (and type, if applicable) of research subjects (animal or human) and/or human anatomical samples projected or required for each task and at each site.

As applicable, estimated times to complete each task should include time for local and

USAMRDC regulatory review and approval, as shown below. Refer to Appendix 1 for additional information regarding regulatory review.

○ For studies involving human subjects, include a subtask that allows at least 2 to 3 months for regulatory review and approval by the USAMRDC Office of Human

Research Oversight (OHRO); this does not include the additional time required for local Institutional Review Board (IRB) review and approval.

FY23 – FY27 DOD USAMRDC Broad Agency Announcement for Extramural Medical Research – 16

○ For animal studies, include a subtask that allows at least 2 to 3 months for regulatory review and approval by the USAMRDC Animal Care and Use Review

Office (ACURO); this does not include the additional time required for local

Institutional Animal Care and Use Committee (IACUC) review and approval.

Attachments 6-15: Additional Documents (as applicable): Attach each as a separate

PDF file, named as indicated in the BAA (e.g., “Impact.pdf,” “Transition.pdf”).

For specific instructions regarding content, titles, and page limits for the Additional

Documents, refer to the BAA.

3. Research & Related Personal Data

This form will be used by the Department of Defense (DOD) as the source of demographic information, such as sex, race, ethnicity, and disability information, for the Project Director

(PD)/PI and all other persons identified as Co-PD(s)/Co-PI(s).

Each proposal/application must include this form with the name fields of the PD/PI and any Co-

PD(s)/Co-PI(s) completed; however, provision of the demographic information in the form is voluntary. If completing the form for multiple individuals, each Co-PD/Co-PI can be added by selecting the “Next Person” button. The demographic information, if provided, will be used for statistical purposes only and will not be made available to reviewers. Applicants who do not wish to provide some or all of the information should check or select the “Do not wish to provide” option.

4. Research & Related Senior/Key Person Profile (Expanded)

The Degree Type and Degree Year fields on the Research & Related Senior/Key Person Profile

(Expanded) form will be used by DOD as the source for career information. In addition to the required fields on the form, applicants must complete these two fields for all individuals that are identified as having the project role of PD/PI or Co-PD/Co-PI on the form. Additional senior/ key persons can be added by selecting the “Next Person” button.

Include the requested information for each person who will contribute significantly to the proposed research project.

In the “PROFILE – Project Director/Principal Investigator” section, enter the PI’s User Name provided by eBRAP into the data field labeled “Credential, e.g., agency login” (Figure 2).

Figure 2. PI’s eBRAP User Name

FY23 – FY27 DOD USAMRDC Broad Agency Announcement for Extramural Medical Research – 17

• Biographical Sketch: This file must be titled “Biosketch_LastName.pdf” where

“LastName” is the last name of the PI or Senior/Key Person.

Biographical sketches must conform to the federal wide Biographical Sketch Common

Form. Applicants may use the instructions provided below, or may use a pdf form created in SciENcv for the NIH or the U.S. National Science Foundation (NSF).

The following provides instructions for submitting the biographical sketch for each individual identified as a Senior/Key Person on the proposal. These instructions serve as the CDMRP's implementation of the Biographical Sketch Common Form developed by the National Science and Technology Council’s Subcommittee on Research Security. A complete list of terms and definitions is available in the National Security Presidential

Memo – 33 (NSPM-33) Implementation Guidance.

Consistent with NSPM-33, individuals are required to disclose contracts associated with participation in programs sponsored by foreign governments, instrumentalities, or entities, including foreign government-sponsored talent recruitment programs. Further, if an individual receives direct or indirect support that is funded by a foreign government-sponsored talent recruitment program, even where the support is provided through an intermediary and does not require membership in the foreign government-sponsored talent recruitment program, that support must be disclosed. Individuals must also report other foreign government-sponsored or affiliated activities. In accordance with 42 USC

19232, the Malign Foreign Talent Recruitment Program Prohibition Statute, individuals are prohibited from being a party in a malign foreign talent recruitment program.

The table entitled NSPM-33 Implementation Guidance Pre- and Post-award Disclosures

Relating to the Biographical Sketch and Current and Pending (Other) Support provides helpful reference information regarding pre-award and post-award disclosures. The table includes the types of activities to be reported, where such activities must be reported in the proposal, as well as when updates are required in the proposal and award lifecycle. A final column identifies activities that are not required to be reported.

http://www.ncbi.nlm.nih.gov/sciencv/ https://www.nsf.gov/bfa/dias/policy/researchprotection/nspm33definitions.pdf#page=1 https://www.nsf.gov/bfa/dias/policy/researchprotection/commonform_biographicalsketch.pdf https://www.nsf.gov/bfa/dias/policy/researchprotection/nspm33definitions.pdf https://www.nsf.gov/bfa/dias/policy/researchprotection/nspm33definitions.pdf#page=2 https://uscode.house.gov/view.xhtml?req=(title:42%20section:19232%20edition:prelim)%20OR%20(granuleid:USC-prelim-title42-section19232)&f=treesort&edition=prelim&num=0&jumpTo=true https://uscode.house.gov/view.xhtml?req=(title:42%20section:19232%20edition:prelim)%20OR%20(granuleid:USC-prelim-title42-section19232)&f=treesort&edition=prelim&num=0&jumpTo=true https://www.nsf.gov/bfa/dias/policy/researchprotection/nspm33definitions.pdf#page=3 https://www.nsf.gov/bfa/dias/policy/disclosures_table/may2024.pdf

FY23 – FY27 DOD USAMRDC Broad Agency Announcement for Extramural Medical Research – 18

Provide only the information requested below in the order it is listed. All elements are required unless otherwise noted. There is no page or character limit to this section of the proposal.

(1) Identifying Information

− Name: Enter the name of the Senior/Key person (Last name, First name, Middle name, including any applicable suffix).

− ORCID of the Senior/Key Person (optional): Enter the ORCID of the

Senior/Key person. The ORCID is a unique, open digital identifier that distinguishes the individual from every other researcher with the same or a similar name.

− Position Title: Enter the current position title of the Senior/Key person.

(2) Organization and Location

− Name: Enter the name of the primary organization of the Senior/Key person.

− Location: Enter the City, State/Province, and Country where the primary organization is located. If the State/Province is not applicable, enter N/A.

(3) Professional Preparation

Provide a list of the Senior/Key person's professional preparation (e.g., education and training), listed in reverse chronological order by start date. Include all postdoctoral and fellowship training, as applicable, listing each separately. Also include the baccalaureate degree or other initial professional education.

− For each entry, provide:

▪ Name of the organization

▪ Location of the organization: Enter the City, State/Province, and Country where the organization is located. If the State/Province is not applicable, enter N/A.

▪ Degree received (if applicable)

▪ Start date of the degree or fellowship program

▪ Month and year the degree was received (or expected receipt date)

▪ Field of study

FY23 – FY27 DOD USAMRDC Broad Agency Announcement for Extramural Medical Research – 19

(4) Appointments and Positions

− A list, in reverse chronological order by start date, of all the individual’s academic, professional, or institutional appointments and positions, beginning with the current appointment (including the associated organization and location). Appointments and positions include any titled academic, professional, or institutional position whether or not remuneration is received, and whether full-time, part-time, or voluntary (including adjunct, visiting, or honorary).

− Senior/Key persons must only identify all domestic and foreign professional appointments and positions outside of the primary organization for a period up to three years from the date the applicant submits the application to the

CDMRP for funding consideration.

− For each entry provide:

▪ Start date: YYYY

▪ End date: YYYY

▪ Appointment or position title

▪ Name of organization

▪ Department (if applicable)

▪ Location of organization: City, State/Province, Country

(5) Products

Provide a list of products that demonstrate the individual’s qualifications to carry out the project as proposed. It is up to the individual to determine how to best organize this listing to demonstrate their ability to carry out the project. Acceptable products must be citable and accessible, including but not limited to:

− Publications, conference papers and presentations

− Website(s) or other internet site(s)

− Technologies or techniques

− Inventions, patents, patent applications and/or licenses

− Other products, such as data, databases, or datasets, physical collections, audio or video products, software, models, educational aids or curricula, instruments or equipment, research material, interventions (e.g., clinical or educational), or new business creation https://www.nsf.gov/bfa/dias/policy/researchprotection/nspm33definitions.pdf#page=1 https://www.nsf.gov/bfa/dias/policy/researchprotection/nspm33definitions.pdf#page=1 https://www.nsf.gov/bfa/dias/policy/researchprotection/nspm33definitions.pdf#page=3

FY23 – FY27 DOD USAMRDC Broad Agency Announcement for Extramural Medical Research – 20

Each product must include full citation information including:

− Names of authors

− Product title

− Date of publication or release

− Website URL

− Other persistent identifier (if available)

− Other relevant citation information (e.g., in the case of publications, title of enclosing work such as journal or book, volume, issue, pages)

If any of the items specified above is not applicable, enter N/A.

Senior/Key personnel who wish to include publications in the products section of the

Biographical Sketch that include multiple authors may, at their discretion, choose to list one or more of the authors and then “et al” in lieu of including the complete listing of authors’ names.

(6) Certification

Each Senior/Key person is required to complete the following certifications regarding the information provided in their Biographical Sketch:

− I certify that the information provided is current, accurate, and complete. This includes but is not limited to information related to domestic and foreign appointments and positions.

− I also certify that, at the time of submission, I am not a party in a malign foreign talent recruitment program.

Misrepresentations and/or omissions may be subject to prosecution and…